A Study of HS-20110 in Participants with Advanced Solid Tumors

Hansoh Pharma

Status and phase: Not yet enrolling; Phase 1

Conditions: Solid Tumors

Treatments: Drug: HS-20110 (Phase Ia：Dose escalation ); Drug: HS-20110 (Phase Ib:Dose expansion )

Study type: Interventional

Funder types: Industry

Identifiers

NCT06892379

HS-20110-101

Details and patient eligibility

About

This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20110 in participants with advanced solid malignant tumors

Enrollment: 475 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males or females, aged ≥ 18 years.
2. Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.
3. Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.1.

Exclusion criteria

1. Participants have received or are receiving the following treatment:

   1. Drug therapy targeting CDH17 (such as small molecule targeted drugs, monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, or chimeric antigen receptor T cells).
   2. Anti-tumor drugs within 14 days prior to the first dose of study treatment; any other IMPs or macromolecular anti-tumor drugs within 28 days prior to the first dose of study treatment.
   3. Local radiotherapy within 2 weeks prior to the first dose of study treatment; irradiation of more than 30% of bone marrow or extensive radiotherapy within 4 weeks prior to the first dose of study treatment.
   4. Major surgery within 4 weeks prior to the first dose of study treatment.
   5. Participants previously treated with drugs that are moderate to strong inhibitors or moderate to strong inducers of cytochrome P450 (CYP) 3A4, strong inhibitors or strong inducers of CYP2D6, P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) or drugs with a narrow therapeutic range that are sensitive substrates of P-gp or BCRP within 7 days prior to the first dose of the IMP. Participants who need to receive these drugs during the study period should also be excluded.
   6. Current use of drugs known to prolong the QT interval or that may cause torsade de pointes. Participants who need to receive these drugs during the study period should also be excluded.
   7. Live vaccine or live-attenuated vaccine within 28 weeks prior to the first dose.

2. Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from prior therapies (except alopecia and residual neurotoxicity).

3. Inadequate bone marrow reserve or hepatic and renal functions.

4. Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins.

5. Participants who are allergic to any component of HS-20110.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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475 participants in 2 patient groups

HS-20110 (Phase Ia：Dose escalation )

Experimental group

Treatment:

Drug: HS-20110 (Phase Ia：Dose escalation )

HS-20110 (Phase 1b Dose expansion)

Experimental group

Treatment:

Drug: HS-20110 (Phase Ib:Dose expansion )